ApprovalTrail

Medical device licence · 1039 · Class 3

ASCENSIA DEX-2

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed February 5, 1999; ended October 25, 2007. It is in Health Canada’s archive of licences no longer in force.
Licence number
1039
Licence holder
Bayer Healthcare Llc Subsidiary Of Bayer CorporationMishawaka, IN, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 5, 1999
Ended
October 25, 2007
Devices covered
7

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ASCENSIA DEX-2 - AUTODISC TEST STRIPS
  • ASCENSIA DEX-2 - DISCS
  • ASCENSIA DEX-2 NORMAL LOW AND HIGH CONTROLS
  • ASCENSIA DEX-2- GLUCOSE MONITOR
  • GLUCOMETER DEX-2 - CONTROLS
  • GLUCOMETER DEX-2 - GLUCOSE METER
  • GLUCOMETER DEX-2 - TEST SENSORS

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.